510(k) K163677
K163677 is an FDA 510(k) premarket notification submitted by 3Shape A/S for the device "Ortho System". The FDA issued a decision of Substantially Equivalent on April 20, 2017. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. 3Shape A/S has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2017
- Date Received
- December 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthodontic Software
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.